Evaluation and decision on applications for Union authorisation
Article 6
1. By way of derogation from Article 44(1), (2) and (3) of Regulation (EU) No 528/2012 the Agency shall prepare and submit to the Commission an opinion on the application within 30 days from the validation of the application in accordance with Article 4 of this Regulation, or, where applicable, on the subsequent date of submission of an opinion on the related reference product in accordance with Article 44(3) of Regulation (EU) No 528/2012. 2. If the Agency recommends the authorisation of the biocidal product, the opinion shall contain at least both the following elements: (a) a statement on whether the conditions laid down in Article 19 of Regulation (EU) No 528/2012 are fulfilled, and a draft summary of biocidal products characteristics, as referred to in Article 22(2) of that Regulation; (b) where relevant, details of any terms and conditions which should be imposed on the making available on the market and use of the biocidal product.